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Yahoo
3 days ago
- Health
- Yahoo
Alkermes narcolepsy drug headed for late-stage testing
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. A potential multibillion-dollar drug is advancing to late-stage testing now that its developer, Alkermes, has in hand positive results from a smaller study focused on a certain kind of narcolepsy. According to Alkermes, the study found all three doses of its drug under evaluation were significantly better than a placebo at improving scores on a test that places participants in a quiet, dark, peaceful room and monitors how awake and alert they are. Alkermes described the results as clinically meaningful, and said all the drug-treated groups achieved 'normative wakefulness' — in this case, taking more than 20 minutes to fall asleep. All doses of the drug, previously dubbed ALKS 2680 and now named alixorexton, were also generally well tolerated. Alkermes said there were no so-called serious treatment-emergent adverse events. Nor were there any treatment-related safety signals seen in participants' vital signs, or on liver, kidney and eye exams. The clinical trial specifically enrolled people with narcolepsy type 1, which, along with excessive sleepiness, is characterized by sudden loss in muscle control. Alkermes intends to present more detailed data at a medical meeting in Singapore in September. In the meantime, an extension study in which all participants from the main trial receive alixorexton is still running. So are a couple other experiments assessing the drug in adults with narcolepsy type 2, or a sleep disorder known as idiopathic hypersomnia. Craig Hopkinson, who serves as Alkermes' chief medical officer while also leading the company's research and development, said in a statement that his team is 'moving forward expeditiously' to start a global Phase 3 testing of the drug. The fresh data are an 'important stride forward' for the alixorexton program, he said, as well as for Alkermes' broader portfolio of therapies that amplify orexin 2 proteins. These results arrived just a week after Takeda announced its own orexin drug, oveporexton, hit the main goals of two late-stage trials, giving the Japan-based pharmaceutical giant the confidence to plan to file for marketing approval in the U.S. and elsewhere by the end of March. Jefferies analyst Stephen Barker wrote in a note to clients that oveporexton could reach $3 billion in peak yearly sales just as a treatment for narcolepsy Type 1. Trailing Takeda are Alkermes and several other companies, including Eisai, Jazz Pharmaceuticals and Centessa Pharmaceuticals. They're each trying to break what Wall Street expects to be a lucrative market, with some estimates holding that between 135,000 and 200,000 people in the U.S. alone have narcolepsy. Johnson & Johnson has an experimental, orexin 2-targeting medicine as well, though it's being developed as a therapy for adult and elderly patients who have major depressive disorder with insomnia symptoms. Joseph Thome, an analyst at TD Cowen, last month reported that his team expects annual sales of Alkermes' drug to peak at $2 billion. That estimate factors in approvals for both narcolepsy type 1 and 2. Whether Alkermes shareholders will be as bullish remains to be seen. Evercore ISI analyst Umer Raffat wrote that many investors 'were on the sidelines' regarding the company's orexin program ahead of Monday's disclosure. They may still be. Alkermes' share price was down by as much as 10% Monday morning, before rebounding somewhat to trade down around 5%. Recommended Reading Takeda to seek approval of new kind of narcolepsy drug after study data
Yahoo
6 days ago
- Business
- Yahoo
Biotech startup funding dried up in second quarter, HSBC finds
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Dive Brief: New data from HSBC Innovation Banking add further evidence venture capital funding for private biotechnology companies has slid lower as the year has progressed, erasing what was a fast start to 2025. According to a report HSBC published Thursday, 'first financings' for biotech startups fell from a total of $2.6 billion in the first quarter to $900 million over the following three months — the lowest total in five quarters. Overall venture funding for biotechs fell from $7 billion to $4.8 billion, tied for the worst quarterly total in the last three years. The number of funding deals involving drug candidates from China continued to climb, meanwhile. Four companies formed around medicines discovered there raised first funding rounds of at least $50 million in the first half of 2025, more than the total number in each of the previous two years. Dive Insight: Even before HSBC's report, there were signs of a biotech funding slowdown. Research the investment bank Jefferies published in May and again in June found a substantial pullback in financing in public companies. Private rounds tracked by BioPharma Dive have gotten larger, but are fewer in number, too, as venture firms appear to be favoring surer bets. Initial public offerings have largely been on pause since the middle of February. HSBC's findings detail the fallout for drug startups more specifically. A combination of worries over pharmaceutical tariffs, research funding cuts and leadership changes at public health agencies drove a slump that led to startups' worst quarter in terms of seed or Series A funding rounds since 2023, according to Jonathan Norris, a managing director at HSBC Innovation Banking. The uncertainty has made investors more conservative, prompting them to shy away from smaller deals and band together for larger fundings, such as 'megarounds' of $100 million or more. These investments allow companies to 'get almost three traditional rounds' through one financing, Norris said. Yet even megarounds dipped from 21 over the first three months to 16 between April and June. And along with that decline, the so-called crossover investors that often support the rounds preceding an IPO retreated from biotech venture deals. Only two of the top eight rounds included new crossover investors, a decline from each of the last two years. 'Many crossover investors are at their own proverbial crossroads, with too many private investments that have yet to IPO and many public companies struggling with low market caps,' Norris wrote in the report. Their disappearance is, in part, due to the poor performance of companies that went public in 2024. The median stock price decline for last year's class was 70% at the end of the first half, according to HSBC. One bright spot is a steadier pace of M&A deals for private companies, which give venture capital firms another chance at investment returns. Last year, 17 drug startups were acquired — the highest total since 2020 — and buyouts are proceeding at a similar pace in 2025. Those deals prove 'you can still get to an exit with early data in the right space,' Norris said. Recommended Reading A longer 'winter': Public funding slowdown heightens pressure on biotech startups Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
10-07-2025
- Business
- Yahoo
AbbVie to pay $700M for trispecific drug from Ichnos Glenmark
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. AbbVie agreed to pay Ichnos Glenmark $700 million upfront for rights to an early-stage experimental trispecific antibody that has shown promise in multiple myeloma. Under the terms of the deal announced Thursday, AbbVie will gain rights to ISB 2001 in North America, Europe, Japan and China. Ichnos Glenmark will be eligible for as much as $1.23 billion more in payments if the medicine reaches certain development, regulatory and commercial milestones and will also receive royalties on sales if the drug reaches the market. Glenmark Pharmaceuticals, which joined with Ichnos Sciences to create Ichnos Glenmark in 2024, will be responsible for development, manufacturing and lead commercialization of the drug in emerging markets. That includes the rest of Asia, Latin America and the Middle East. AbbVie is betting on a treatment that promises to knock out cancer cells by engaging three different targets, building on the success of bispecific drugs in oncology. ISB 2001 binds CD3 on T cells, while also hunting for two proteins, BCMA and CD38, that are expressed on cancerous cells. The company says the triple action can eliminate more myeloma cells more effectively, offering the potential of a cure for the disease. AbbVie also aims to test the approach on autoimmune diseases, a therapeutic area where multifaceted antibody drugs have recently attracted interest. The promise of ISB 2001 led the Food and Drug Administration to award Orphan Drug and Fast Track Designations to the drug, smoothing the path for faster development. So far, the experimental treatment has only reached Phase 1 testing. Preliminary results showed an overall response rate of 79% among patients with relapsed or refractory multiple myeloma, according to data presented at the recent American Society of Clinical Oncology's annual meeting. The drug was generally well tolerated, the company said. Sign in to access your portfolio
Yahoo
01-07-2025
- Business
- Yahoo
Atai and Beckley, set to merge, reveal study success for psychedelic drug
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Atai Life Sciences and Beckley Psytech are making plans to push the psychedelic drug mebufotenin into Phase 3 testing after it safely and significantly reduced symptoms of treatment-resistant depression in a Phase 2b study. Shares of Atai jumped 20% after the companies' announcement Tuesday. Atai also announced a $50 million private placement in a financing round led by Ferring Ventures and Apeiron Investment, the family office of Atai founder and Chairman Christian Angermayer. With the successful study in hand and a new infusion of cash, the companies are proceeding with plans to merge in the second half of this year. The combination, announced in June, was contingent on positive results from the Phase 2b trial. Atai had previously scooped up a 36% stake in privately held Beckley in 2024. Atai and Beckley are looking to benefit from a new openness to psychedelic drugs for the treatment of mental health conditions. Both Health and Human Services Secretary Robert F. Kennedy Jr. and Food and Drug Administration Commissioner Martin Makary have touted the potential benefits of the medicines for patients, while Johnson & Johnson's Spravato, a derivative of ketamine, has generated blockbuster sales. Investors so far have shown a willingness to support the research but are looking for strong results. Compass Pathways recently failed to meet that mark with a medicine that succeeded in a Phase 3 trial but nevertheless disappointed shareholders by only reducing scores on a scale used to gauge depressive symptoms by a mean difference of 3.6 points compared with placebo. Beckley's mebufotenin showed a difference of 5.3 points and 6.3 points for the two therapeutic doses it tested as compared with a low-dose group used as a control when measured at Day 29 after treatment. Wall Street was looking for a difference of at least 5 points, Jefferies analyst Andrew Tsai wrote in a note to clients. Like Spravato, mebufotenin is administered through the nose. Atai and Beckley said participants in its study generally were able to leave the clinic within 90 minutes, which would put the drug in the conventional treatment window established by Spravato. The study also found no serious side effects and no evidence of suicidal intent or behavior in patients given mebufotenin. Researchers tested an 8 milligram dose and a 12 milligram dose against an 0.3 milligram control. The larger difference in depression symptom measurement was in the 8 mg dose, though the companies said they consider efficacy equivalent between the 8 mg and 12 mg doses. They plan to advance the 8 mg dose into Phase 3 testing after consulting with regulators. The companies said improvements were seen as early as one day after treatment and generally lasted at least eight weeks. While the results need to be confirmed in a continuing open-label study of a second dose and the eventual Phase 3 trial, the data suggests Atai and Beckley may be able to offer a longer window between treatments, possibly giving their drug an advantage over rivals such as Spravato, Tsai said. Recommended Reading Compass' big psychedelic study doesn't impress investors
Yahoo
01-07-2025
- Business
- Yahoo
Sage to lay off most staff amid Supernus buyout
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Sage Therapeutics will lay off 338 employees, the vast majority of its workforce, while in the process of being acquired by Supernus Pharmaceuticals, according to a Massachusetts regulatory filing. The move comes less than two weeks after Supernus announced it would buy the developer of the postpartum depression drug Zurzuvae for $561 million, a move that one analyst described as an 'unremarkable' outcome for a company that was once worth billions of dollars. The layoffs will be effective Aug. 22, according to the filing. It is unclear how the layoffs will impact ongoing R&D programs Supernus will acquire as part of its deal to buy Sage. Sage has seen its share of ups and downs in the 15 years since its launch. The biotech sought to develop medicines for a variety of brain disorders, including epilepsy, Huntington's disease and major depressive disorder. At its peak, Sage commanded a share price of nearly $200 apiece. It managed to develop and market an intravenous treatment for postpartum depression, Zulresso, but failed to generate notable sales. An oral drug Sage developed next, Zurzuvae, was approved by the Food and Drug Administration in 2023. However, the agency rejected the company's application to permit wider use among people with MDD. Other hurdles included a string of clinical trial busts with its neurology programs. Last fall, Sage cut one-third of its workforce and, earlier this year, said it would pursue strategic alternatives after rebuffing an offer from Biogen to buy out the struggling company. Sage employed 353 full-time employees as of the beginning of February, according to an annual filing. Of those, nearly one-third, or 122 employees, were involved in research and development. Neither Sage nor Supernus responded to BioPharma Dive's request for comment. Recommended Reading Amarin, Fibrogen lay off staff as biotech cost cutting continues Sign in to access your portfolio
